Prophylactic Cranial Irradiation in Extensive-stage Small Cell Lung Cancer

NCT04947774 | Unknown DMC

• 1 other identifier: NCC2622
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The prognosis of extensive-stage small cell lung cancer is still very poor, even for those who received chemotherapy and immunotherapy. This experimental study is a real-world research design to evaluate the effectiveness and safety of prophylactic cranial irradiation in patients with extensive-stage small cell lung cancer who with first-line chemotherapy combined with immunotherapy.

Conditions

Extensive-stage Small-cell Lung Cancer

Keywords

Small-cell Lung Cancer; Radiation:prophylactic cranial irradiation

Outcome Measures

Primary Outcomes (1)

• Progression-free survival in the brain

  The length of time during and after treatment for a disease in which the patient lives with the disease but the intracranial lesions do not worsen

  1 year

Secondary Outcomes (4)

• Progression-free survival (PFS)

  1 year

• Overall survival (OS)

  1 year

• Adverse events

  1 year

• The cognitive function of the patient

  1 year

Other Outcomes (1)

• Exploratory end point including biomarkers

  1 year

Study Arms (2)

prophylactic cranial irradiation group

The extensive-stage SCLC patients will receive prophylactic cranial irradiation after standard first-line chemotherapy combined with immunotherapy, until disease progression or death.

Radiation: Prophylactic Cranial Irradiation

Observation group

Patients with extensive-stage SCLC do not receive preventive craniocerebral irradiation after standard first-line chemotherapy combined with immunotherapy until the disease progresses or death.

Interventions

Prophylactic Cranial Irradiation RADIATION

The extensive-stage SCLC patients will receive prophylactic cranial irradiation ±immunotherapy after standard first-line chemotherapy combined with immunotherapy, until disease progression or death

Also known as: Immunotherapy

prophylactic cranial irradiation group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

It is planned to enroll patients who have completed and response to first-line chemotherapy combined with immunotherapy, Later immunotherapy treatments are open

You may qualify if:

• Sign written informed consent;
• With extensive small cell lung cancer;
• Previously received first-line standard chemotherapy, with treatment response of CR or PR;
• Can tolerate the radiotherapy process;
• Be over 18 years old
• Life expectancy ≥ 12 weeks;
• With the Eastern Cancer Cooperative Group (ECOG) score 0-1
• After the systemic treatment was received, there was no brain metastasis on MR before brain preventive irradiation.

You may not qualify if:

• Exclude subjects with central nervous system (CNS) metastasis at the first diagnosis;
• Pregnancy or breastfeeding;
• Any other conclusive medical, psychiatric and/or social reasons determined by the researcher;
• Subjects who have previously suffered from other malignant tumors (excluding non-melanoma skin cancer and the following carcinoma in situ: bladder, stomach, colon, endometrial, cervical/dysplasia, melanoma or breast cancer) are not allowed to participate in the study. Unless he/she has been in complete remission at least 2 years before enrolling in the study, and does not need to receive other treatments or does not need to receive other treatments during the study;
• Researchers believe that the treatment methods used in the study can cause harm or cause basic diseases whose toxicity is difficult to judge when judging adverse events.

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer Insititute and Hosiptal of Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

Related Publications (16)

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• Rimner A, Wu AJ, Grills IS. What Is the Impact of Hippocampus Avoidance-Prophylactic Cranial Irradiation on Neurocognitive Preservation? J Thorac Oncol. 2021 May;16(5):722-724. doi: 10.1016/j.jtho.2021.02.026. No abstract available.

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MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

Immunotherapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Immunomodulation; Biological Therapy; Therapeutics

Study Officials

• Bi Nan, MD

  Cancer Hospital, CAMS and PUMC

  STUDY DIRECTOR

Central Study Contacts

Liu Wen-Yang, MD

CONTACT

8613810753633; liuwenyang26@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 24, 2021
• First Posted: July 1, 2021
• Study Start: November 1, 2020
• Primary Completion: January 1, 2022
• Study Completion: October 1, 2022
• Last Updated: September 22, 2021

Record last verified: 2021-09

Locations

CN (1)